Kornimate/medical-research-clean huggingface dataset:
facbc pet/ct for recurrent prostate cancer

Conditions: Prostate Cancer

Summary: hypothesis:anti-\[18f\]facbc pet-ct will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients. this is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. this substance has a natural tendency to go to prostate tissue. the substance is called \[18\]facbc and it is given in the form of an injection into a vein. after the substance reaches the prostate, scans called pet or positron emission tomography, are done. this is similar to having cat scans or x-rays. usually a compound called \[18\]fdg is used for pet scans but this substance is eliminated by the kidneys and cannot reach the prostate. this substance called \[18\]facbc is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. it is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done. anti-\[18f\]facbc pet-ct will be compared to prostascint (in-capromab pendetide) which is the conventional imaging for prostate cancer. investigators will be blinded of the intervention. this study will look at how the \[18\]facbc goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.


Eligibility criteria:
study now closed for recruitment inclusion criteria: * patients must be 18 years of age or older. * patients will have been originally diagnosed with localized (stage t1c, t2, or t3 ) prostate carcinoma and have undergone what was considered definitive therapy for localized disease. * in the case of brachytherapy, cryotherapy, or external beam radiation, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "psa bump." * patient will have suspicion of recurrent prostate carcinoma as defined by: astro criteria of three consecutive rises of psa or earlier if clinically appropriate, and/or nadir + 2.0 after radiotherapy, and/or greater than 0.3 after prostatectomy. * ability to lie still for pet scanning * patients must be able to provide written informed consent. exclusion criteria: * age less than 18. * greater than t3 disease in past * prior prostatectomy or 2 years since brachytherapy, cryotherapy, or external beam radiation therapy. * does not meet above criteria of suspicious psa elevation * inability to lie still for pet scanning * cannot provide written informed consent. * bone scan findings characteristic for metastatic prostate carcinoma * less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation).
interventions for sleep problems in early childhood

Conditions: Sleep Disorder

Summary: this study will inform the field about underlying mechanisms associated with infant sleep problems and will deepen the understanding of the intervention process. the study will provide detailed information on the intervention process itself and will explore how behavioral sleep interventions affect broader infant outcome.


Eligibility criteria:
inclusion criteria: * infants at age range 9-18 months; * healthy infants with no significant health problems; * two-parents families; * parents who master the hebrew language. * significant sleep problem lasting more than 3 months: our definition for a significant sleep problem in this age range is based on meeting at least one of the following three criteria for the baseline week: * an average of three or more night-wakings per night; * an average wake period of at least 30 minute per night between sleep onset and morning rise time; * more than 30 minutes to fall asleep each night with protests for attention. exclusion criteria: * infants not meeting the inclusion criteria at the baseline assessment will be excluded from the study.
efficacy and safety of oral bosentan in pulmonary arterial hypertension class ii

Conditions: Pulmonary Hypertension

Summary: the present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (pah) class iii and iv, to patients suffering from pah class ii.


Eligibility criteria:
inclusion criteria: * pah nyha class ii * significant elevation of mean pulmonary arterial pressure * significant elevation of pulmonary vascular resistance at rest * limited 6-minute walk distance exclusion criteria: * pah secondary to portal hypertension, complex congenital heart disease or reverse shunt * restrictive or obstructive lung disease * significant vasoreactivity * treatments for pah (within 4 weeks of randomization)

Keywords: pulmonary arterial hypertension pah pph bosentan early
the effect of nitroglycerine on microcirculatory abnormalities during sepsis

Conditions: Sepsis; Septic Shock

Summary: the purpose of this study is to evaluate the effect of nitro-glycerine on the microcirculation (smallest vessel type) in patients with severe sepsis and septic shock. nitro-glycerine is a well known medicine in cardiology and is used to improve circulation. in this icu the investigators use nitro-glycerine to improve the organ perfusion; but it's no common therapy in the rest of the world. the investigators now compare nitro-glycerine and placebo by looking to the sublingual microcirculation by a small camera (sdf imaging).

this study starts at admission of the patient on the icu. in the next 24 hours the patient receives nitro-glycerine or placebo (randomised). at time = 0, ½, 2, 12 and 24 hour we evaluate the microcirculation by sdf imaging and monitoring of hemodynamic parameters. informed consent is obtained of the relatives.

Eligibility criteria:
inclusion criteria: * severe sepsis * proven infection * informed consent exclusion criteria: * age \< 18 years * pregnancy * use of nitroglycerine within 24 hours prior to icu admittance * necessity to use nitroglycerine iv for instable angina

Keywords: microcirculation sepsis nitroglycerine sdf imaging
music in the emergency department (ed)

Conditions: Anxiety

Summary: this will be a randomized controlled study evaluating the effect of a music-listening intervention compared to standard care (control) during patient visit to the emergency department (ed). randomization will be done with consecutive sealed envelopes. data collection will be prospective with administration of the state trait anxiety inventory and collection of physiologic parameters (pain level, heart rate, blood pressure). retrospective data will also be collected for covariate analysis (age, race/ethnicity, emergency severity index (esi), pain medications administered during the ed visit, pain scores throughout ed visit, chief complaint, and ed discharge diagnosis).

a visit to the emergency department (ed) is anxiety provoking for patients by nature. contributing factors may include the sudden timing of the visit, a noisy environment, and waiting in anticipation of a serious diagnosis or bad news. studies suggest that nearly 75% of adult ed patients may experience mild to severe anxiety in relation to the ed visit, but not directly related to their chief complaint. anxiety can have deleterious effects on a patient in the clinical setting. patients may report excessive pain complaints and manifest the typical signs and symptoms of anxiety (e.g. anorexia, dry mouth, nausea, chest pain), which can complicate diagnosis. patient anxiety can also impose barriers to communication with ed staff, hindering successful delivery of important medical information. a visit to the ed may be particularly distressing for older adults (age 65+), for they are more likely than younger adults to have a greater ed length of stay before discharge home, receive more diagnostic tests and venipuncture for intravenous (iv) access, and have poorer pain care. music listening as an anxiolytic has been shown to be effective across a variety of clinical settings, however there is a relative paucity of published data on the use of music listening for adult patients in the ed. no published studies, to the investigators' knowledge, have evaluated the effect of music listening on older adults in the ed.

Eligibility criteria:
inclusion criteria: * present to the ed * aged 65 or over * speak english or spanish exclusion criteria: * individuals who are deaf * prisoners * individuals who cannot give informed consent

Keywords: anxiety music intervention emergency department (ed)
rituximab, bortezomib,bendamustine , dexamethasone, patients with mantle cell lymphoma

Conditions: Lymphoma

Summary: rationale: monoclonal antibodies, such as rituximab, can block cancer growth in different ways. some block the ability of cancer cells to grow and spread. others find cancer cells and help kill them or carry cancer-killing substances to them. bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. drugs used in chemotherapy, such as doxorubicin, dexamethasone, and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. giving combination chemotherapy together with rituximab and bortezomib may kill more cancer cells. purpose: this phase ii trial is studying how well giving rituximab together with bortezomib, doxorubicin, dexamethasone, and chlorambucil works as first-line therapy in treating older patients with stage ii, stage iii, or stage iv mantle cell lymphoma.

objectives: primary * evaluate the efficacy of rituximab, bortezomib, doxorubicin hydrochloride, dexamethasone, and chlorambucil as first-line therapy in patients with stage ii-iv mantle cell lymphoma. secondary * determine the complete response rate in these patients. * determine the efficacy, in terms of complete and overall response, by f18 fludeoxyglucose scan. * determine overall, disease-free, and event-free survival of these patients. * assess tolerability of this regimen in these patients. * evaluate the impact of factors, described in previous protocols, on response to therapy and survival. * assess the impact of residual disease in cerebrospinal fluid on survival. outline: this is a multicenter study. patients receive rituximab iv on day 1 (days 1 and 8 of the first course only); bortezomib iv on days 1, 4, 8, and 11; doxorubicin hydrochloride iv continuously over 24 hours on days 1-4; dexamethasone iv on days 1-4; and oral chlorambucil on days 20-29. treatment repeats every 5 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. patients who achieve at least 50% response receive 2 additional courses of therapy.

Eligibility criteria:
disease characteristics: * diagnosis of mantle cell lymphoma * stage ii-iv disease * no neuromeningeal disease patient characteristics: * who performance status 0-2 * no prior cancer except for carcinoma in situ of the cervix or basal cell skin cancer * lvef \> 50% * hiv-negative * hepatitis b- and c-negative * no hepatocellular, renal, or bone marrow insufficiency unrelated to lymphoma prior concurrent therapy: * not specified

Keywords: contiguous stage ii mantle cell lymphoma noncontiguous stage ii mantle cell lymphoma stage iii mantle cell lymphoma stage iv mantle cell lymphoma
a multi-modality surveillance program for women at high risk for breast cancer

Conditions: Breast Cancer

Summary: this study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.


Eligibility criteria:
inclusion criteria: - known brca1 or brca2, tp53, palb2, pten, cdh1 and stk11 carrier. women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high prs. or * with life time risk of 30% or higher, based on polygenic risk score that integrates genetic and non-genetic factors or * 5-years risk ≥ 6% for women 40-64 or * 5-years risk ≥ 6% for women 65+ and breast density c or d and a lifetime risk \>= 20% (bcsc+prs ltr or tyrer-cuzick ltr) or * patients with history of chest wall radiation received before age 35. or * to promote health equity, women of african ancestry \< 45 years with at least one 1st or 2nd degree relative with breast or ovarian cancer are eligible because prs scores are not currently reported for aa women. * must be at least 25 years old. * willing to travel to participating site for imaging studies as well as any necessary follow-up procedures. * be able to give informed consent. * patients with prior history of breast or ovarian cancer are eligible if they have completed all active treatments and are cancer free for two years. exclusion criteria * undergoing active cancer treatment at the time of enrollment. * current pregnancy or plans for pregnancy within two years of enrollment. * presence of a pacemaker or any other metallic foreign object in their body that interferes with an mri. * breast surgery within two weeks of study entry. * women with history of bilateral mastectomy are not eligible * history of kidney disease or abnormal kidney function. * history of dye allergy unless it can be mediated with antihistamines and/or steroids * women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, parp inhibitors as adjuvant therapy or participating in a chemoprevention trial.
efficacy of modification of lifestyle in the treatment of ankylosing spondylitis: a pilot study

Conditions: Arthritis; Rheumatic Diseases; Autoimmune Diseases

Summary: axial spondyloarthritis (axspa) is a chronic inflammatory immune disorder with a global prevalence that ranges from 20 to 160 cases per 10000 individuals. axspa has two forms of clinical presentation (radiographic and non-radiographic) based on the presence or absence of radiographic sacroiliitis. this condition mostly affects the vertebral spine, and is characterized by joint pain and stiffness, fatigue, and restricted function, which leads to a substantial physical, psychological, and socioeconomic burden. the clinical management of axspa needs to combine pharmacological and non-pharmacological approaches to reduce inflammation and improve health-related quality of life. the aim of the study will be to determine if a 12-week probiotic supplementation will be more effective than an online-delivered strength training program at improving functional capacity in adults with non-radiographic axspa. as a secondary aim, we will compare the impact of both interventions on disease activity, spinal mobility, quality of life and biochemical measures. this will be the first randomized controlled trial where probiotics are compared with an active intervention.


Eligibility criteria:
inclusion criteria: * participants must be aged 18 years or older and have a confirmed diagnosis of non-radiographic axspa following the 2009 assessment of the spondyloarthritis international society classification criteria exclusion criteria: * any systemic disease or comorbidity that may severely impair exercise capacity. * a high sensitivity c-reactive protein 10-fold greater than the normal upper limit (2.87 mg/l). * any changes to medical treatment within the previous 2 months, and having an active peripheral arthritis
benefits of total intravenous anesthesia compared with inhaled anesthesia in cardiovascular surgery

Conditions: Cardiovascular Surgical Procedure

Summary: this study compares the difference in proinflammatory markers interleukin 6 (il-6), tumor necrosis factor alpha (tnfα) and cortisol in patients undergoing cardiovascular surgery to asses if there is a benefit of using intravenous total anesthesia (tiva) over inhaled anesthesia for this procedures.

il-6, tnfα and cortisol will be measure at the beginning of the cardiovascular surgery and 20 minutes after the cardiovascular bypass ends to calculate the difference between them and compare if there is any statistical difference between the proinflammatory markers with the two anesthesia techniques.

Eligibility criteria:
inclusion criteria: scheduled for cardiovascular surgery american society of anaesthesiologists (asa) physical status classification ii-iv bmi \< 25 hba1c \< 7% exclusion criteria: diabetic patients known allergy to propofol

Keywords: inhaled anesthesia total intravenous anesthesia
a living tissue bank of patient-derived organoids from glioma tumors

Conditions: Low-grade Glioma; High Grade Glioma

Summary: there is a high medical need to improve treatment outcome for high-grade and low-grade glioma since no curative treatment is available. to achieve this goal, a broader understanding is needed of the causes of inter-and intratumoral heterogeneity; glioma dedifferentiation and invasion; the major determinants of malignancy and treatment failure in glioma patients. patient-derived organoid (pdos) of high-grade gliomas and low-grade gliomas will be used to identify the mechanisms that underlie this malignant behaviour and treatment resistance. this insight may be used to develop patient avatars to simultaneously test multiple new treatment modalities that are predictive for survival and quality of life of glioma patients.

to establish primary patient-derived three-dimensional organoid cultures from low grade and high-grade gliomas to study the mechanisms that contribute to i.e. resistance to radiotherapy and/or chemotherapy and immunotherapy, dedifferentiation, tumor invasion among others, in primary and recurrent tumors. primary objectives: 1. establishment of primary patient-derived organoids (pdo) of 'de novo' and recurrent high-grade glioma (hgg) and low-grade glioma (lgg) 2. phenotypic, genetic, epigenetic and transcriptomic characterization of hgg and lgg organoids and resemblance to the parental tumor (i.e. characterization of specific cell populations and genomic and transcriptomic profiles of pdos) 3. investigation of combinations of new or standard glioma systemic treatments (i.e immunotherapy, chemotherapy) with or without radiation (i.e. protons, photons). secondary objectives 1. establishment of co-cultures of hgg and lgg organoids with immune cells. 2. investigation of radiation-triggered cell death mechanisms on pdos after irradiation with photons and protons. 3. investigation of dedifferentiation mechanisms of lgg to hgg in the context of radiation w/wo immunotherapy.

Eligibility criteria:
inclusion criteria: * mri diagnosis of low grade glioma (lgg) or high grade glioma (hgg) * age 18 years or older * patient is eligible for a resection of the tumor exclusion criteria: * contra-inidication for neurosurgical resection of the tumor. * incapacitated patient, unable to give informed consent.

Keywords: prospective study patient-derived organoids
the 18f peel-way sheath versus the 18f access sheath with a suction-evacuation function mpcnl for the management of 2-5cm size kidney stones

Conditions: Renal Calculi

Summary: percutaneous nephrolithotomy (pnl) has been considered as the first-line choice for the management of \>20mm kidney stones. microchannel percutaneous nephrolithotomy (mini pcnl) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications. at present, the use of percutaneous renal surgery in our country is more than 18f plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by guohua zeng and so on. but there is still a lack of high quality evidence of evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness. therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size kidney, and ultimately benefit patients with 20mm.

percutaneous nephrolithotomy (pnl) has been considered as the first-line choice for the management of \>20mm kidney stones. microchannel percutaneous nephrolithotomy (mini pcnl) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications. at present, the use of percutaneous renal surgery in our country is more than 18f plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by guohua zeng and so on. but there is still a lack of high quality evidence of evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness. therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size kidney, and ultimately benefit patients with 20mm.

Eligibility criteria:
inclusion criteria: * patients consent for percutaneous renal stone removal * age 18 to 70 years * normal renal function * asa score ⅰ and ⅱ * renal stones 20-50mm exclusion criteria: * patients with solitary kidney * uncorrected coagulopathy and active urinary tract infection (uti) * morbid obese patients * patients who underwent transplant or urinary diversion * congenital abnormalities * patients will be excluded from the study if the undergoing standard pnl/mini-perc have purulent fluid in the initial puncture

Keywords: renal pelvic pressure
effects of parental behavior on child anxiety regulation

Conditions: Separation Anxiety Disorder; Social Phobia; Generalized Anxiety Disorder

Summary: does parenting style affect emotion regulation among children who initially demonstrate high levels of fear and anxiety? although recent correlational research has demonstrated a linkage between parental behaviors, such as excessive intrusiveness, and children's manifestations of fear and anxiety, it is not clear if parenting behaviors directly influence children's ability to regulate these emotions. alternatively, these parental behaviors may be elicited by children who express fears and anxieties more frequently than other children do. experimental research designs would offer a more definitive test of these competing explanations of the extant correlational findings. intervention studies, in particular, can test whether experimentally manipulating current family interaction patterns affects children's ability to regulate emotion. this study provides a preliminary experimental test of the relationship between parental behavior and children's regulation of fear and anxiety. some 40 clinically anxious youth, aged 6-13, were randomly assigned to a family intervention program for childhood anxiety problems, which includes extensive parent communication training, or a child intervention program without parent-training. by comparing these two interventions, we tested if it was possible to improve parenting behaviors-such as intrusiveness-through intensive parent-training, above and beyond the effects of involving children in a child intervention program. we then tested the impact of this change in parental behaviors on children's ability to regulate fear and anxiety. we hypothesized that parent-training would reduce intrusiveness, which would in turn improve children's anxiety outcomes.


Eligibility criteria:
inclusion criteria: * the child met dsm-iv criteria for a diagnosis of a principal anxiety disorder based on a semi-structured interview * the child was not taking any psychiatric medication at the initial assessment, or was taking a stable dose of psychiatric medication (i.e., at least one month at a stable dose prior to the baseline assessment), and * if medication was being used, families stated an intention to maintain that dose throughout the study. exclusion criteria: * the child was currently in child-focused psychotherapy * the family was currently in family therapy or a parenting class * either the child or the parents evidenced psychotic symptoms * the child began taking psychiatric medication or increased his/her dose of medication during the intervention, or * for any reason the child or parents appeared unable to participate in the intervention program.